MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH C-TAPER COCR LFIT HEAD 44MM/+5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 06-4405

Device Problem Mechanical Problem (1384)

Patient Problems Injury (2348); Inadequate Osseointegration (2646)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

As reported: "procedure: left hip revision.Pre-op diagnosis: mechanical loosening of left hip.Per surgeon.Stem was well fixed.Went to 44 +10 head for stability.No further information available per hospital".A 44 +5 cocr head and 44h poly liner were revised to a 44+10 cocr head and another 44h poly liner.Rep provided a pre-revision x-ray, revision implant stickers, and pictures of the explants.

• Brand Name: C-TAPER COCR LFIT HEAD 44MM/+5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joanne mahony ; ida industrial estate; carrigtwohill NA ; 214532800
• MDR Report Key: 8958531
• MDR Text Key: 156566500
• Report Number: 0002249697-2019-03058
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327032673
• UDI-Public: 07613327032673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Catalogue Number: 06-4405
• Device Lot Number: PYYMNA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 09/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 86